Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Geistlich Pharma AG | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
This study aims to characterize the healing pattern following soft tissue augmentation procedure concomitant to implant placement.
This study will characterize, for the first time, the healing pattern of soft tissues around dental implants in case of soft tissue augmentation and in comparison, to normal healing.
An innovative and comprehensive geometric/thermal imaging analysis will be employed that is non-contact and non-invasive to patients and will allow to characterize the healing process in a 2D-3D dimensional and volumetric way.
This approach, combined with LSCI and clinical and radiographic outcomes, will provide new data on the biology and critical phases of soft tissue healing around implants, as well as on the stability and aesthetics of the peri-implant tissues with different grafts.
Patient-reported outcome measurements (PROMs) will also be used to assess the level of pain and discomfort associated with soft tissue augmentation procedures.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No Soft tissue augmentation surgery | Placebo Comparator | No soft tissue augmentation concomitant to implant placement. Negative control group. |
|
| Soft tissue augmentation surgery with Fibro-Gide | Experimental | Soft tissue augmentation concomitant to implant placement with a porcine, volume-stable cross-linked collagen matrix (Fibro-Gide, Geistlich Pharma AG, Wolhusen, Switzerland). Test group. |
|
| Soft tissue augmentation surgery with patient's CTG | Active Comparator | Soft tissue augmentation concomitant to implant placement with a connective tissue graft (CTG) taken from the patient's palate or retromolar area. Positive control group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Soft tissue augmentation surgery with CTG | Procedure | An epithelial-connective tissue graft of approximately 2-3 mm of thickness and adequate length will be taken from the palate or retromolar region of the patient and de-epithelialized with a scalpel (ideally a thickness of 1.5-2.0mm). The connective tissue graft (CTG) obtained will then be positioned buccally to the dental implant and sutured to the internal side of the flap so to provide soft tissue bulk at the level of the neck of the implant and simulate a root prominence for the missing tooth. |
| Measure | Description | Time Frame |
|---|---|---|
| 3D intra-oral volume changes in mucosal soft tissue following augmentation | Those changes will be assessed by capturing 3D intra-oral scans at the different time-points. | Immediately after implant placement. |
| 3D intra-oral volume changes in mucosal soft tissue following augmentation | Those changes will be assessed by capturing 3D intra-oral scans at the different time-points. | 7, 14 and 30 Days post implant placement |
| 3D intra-oral volume changes in mucosal soft tissue following augmentation | Those changes will be assessed by capturing 3D intra-oral scans at the different time-points. | 12 weeks and 16 weeks post- implant loading. |
| 3D intra-oral volume changes in mucosal soft tissue following augmentation | Those changes will be assessed by capturing 3D intra-oral scans at the different time-points. | 12 month post- implant loading. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in gingival thickness | Changes in gingival thickness from the time of implant placement (with or without graft) and 12 weeks after implant placement assessed by a caliper | implant placement to 12 weeks after implant placement |
| 3D extra-oral volumetric changes |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Nikos Donos, PhD | Barts & The London School of Medicine & Dentistry, QMUL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barts and The London Dental Hospital | London | E1 2AD | United Kingdom | |||
| Centre for Oral Clinical Research (COCR) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D016388 | Tooth Loss |
| D009057 | Stomatognathic Diseases |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D014076 | Tooth Diseases |
Not provided
Not provided
The study will includes 3 groups randomised in parallel.
Not provided
Not provided
Due to the nature of the intervention, both participants and clinicians performing the surgical intervention will be un-blinded.
Conversely, outcome examiners will be blinded to treatment allocation throughout the whole study duration.
|
| Soft tissue augmentation surgery with Fibro-Gide | Procedure | Fibro-Gide will be used to obtain buccal soft tissue augmentation. Fibro-Gide will be trimmed with a scalpel and adjusted in size and thickness to better adapt to the area buccal to the implant. In particular, the graft will be shaped in order to obtain a graft of approximately 2-3 mm of thickness and adequate length. Fibro-Gide will then be sutured to the inner side of the buccal flap, before repositioning the flap and suturing it in a tension-free way. |
|
| No soft tissue augmentation | Procedure | During implant placement surgery, no soft tissue augmentation will be performed |
|
3D extra-oral morphometric changes assessed with a facial scanner |
| baseline, immediately after implant placement, 7, 14 and 30 days after implant placement |
| 2D-3D intra-oral thermal changes | 2D-3D intra-oral thermal changes using an infrared, contact-free, thermal camera | baseline to 1, 3, 7, 14 and 30 days after implant placement |
| changes in vascularisation | Changes in revascularization in the area of the implant surgery with laser speckle contrast imaging | before and immediately after implant placement, and at post-operative days 1, 3, 7, 14, and 30 |
| soft tissue aesthetics | Papilla Fill Index and Pink Aesthetic Score | At implant loading and at 12 months after loading. |
| changes in height of keratinised tissue | changes in height of keratinised tissue measured with a probe | baseline to 30 days, 12 weeks and 16 weeks after implant placement and 12 months post loading |
| Patients' reported outcomes (PROMS) in oral impact on Daily Performances (OIDP) questionnaire (OIDP) | The OIPD is a well validated and frequently used PROMs in studies of oral health. It is a composite measure of the impacts of oral health on the quality of life of people. The OIDP focuses on the impact of oral health on the quality of life of people. The OIDP focuses on the impact that the conditions of the teeth and social wellbeing of the person. More specifically, it assesses the impact of oral conditions on basic daily life activities and behaviours (eating, speaking, cleaning teeth, going out, relaxing, smiling, major work or role, emotional stability, social contact). For each performance, both the frequency and severity of oral impacts are assessed. The overall OIDP score ranges from 0 to 100, with higher scores indicating worse quality of life. | At basline, 3 months (visit2, 3 and 4), 1 week from visit 2, 2 weeks form visit 2, 1 month from visit 2. |
| PROMs based on the evaluation of global changes in quality of life | Global ratings on health and quality of life will be provided through two methods:
The response will be scored on a six-point scale as:
| At basline, 3 months (visit2, 3 and 4), 1 week from visit 2, 2 weeks form visit 2, 1 month from visit 2. |
| PROMs based on the evaluation of patient's perception about therapy | The extent of discomfort and/or pain experienced will be evaluated using a 100-mm horizontal visual analogue scale (VAS). The anchors for each end of the scales will be designated as none and extreme. Patients will be also instructed to quantify the analgesic medication taken. In addition, the extent of discomfort, root hypersensitivity, oedema, hematoma, high fever and interference in daily activities during the first post-therapy week will be evaluated in the same way. | At basline, 3 months (visit2, 3 and 4), 1 week from visit 2, 2 weeks form visit 2, 1 month from visit 2. |
| Post-operative swelling and oedema | A series of subtracted images from the baseline will accurately identify the area and magnitude of the swelling, changes in facial shape, volume and temperature to monitor/quantify the healing. For every patient, a person specific template of postoperative facial swelling/oedema pattern will be created for sequential swelling/thermal changes or oedema volume measurements that will be applied on a unique alignment of the patient's specific consecutive imaging surfaces (self-defined positioning based on patients facial features). | At basline, 3 months (visit2, 3 and 4), 1 week from visit 2, 2 weeks form visit 2, 1 month from visit 2. |
| London |
| E1 2AD |
| United Kingdom |